News & Analysis as of

Compliance Life Sciences

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Morrison & Foerster LLP

Immersive Technologies: The Uncertain Regulatory Landscape

Immersive technologies are at the forefront of innovation in the consumer technology and life sciences industries, but regulators are struggling to fit these devices, which blend clinical software with commercial headsets,...more

Fenwick & West LLP

Disclosure Trend: Risk Factors Post-Chevron

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Life sciences companies are adding risk factor language in response to the U.S. Supreme Court overturning the Chevron Doctrine. As you may recall, the U.S. Supreme Court recently overturned the Chevron Doctrine....more

Smart & Biggar

Discussion Guide for PMPRB Phase 2 Consultations on New Guidelines outlines proposed new framework for patented medicine price...

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As previously reported, the Patented Medicine Prices Review Board (PMPRB) published a Discussion Guide for Phase 2 Consultations on New Guidelines as part of a three-phase consultation process that started in September 2023....more

Arnall Golden Gregory LLP

The Boys Are Back in Town: FDA’s Draft Guidance for Compliance With the Phase-Out of LDT Enforcement Discretion

Thin Lizzy famously declared in their 1976 hit, “The Boys are Back in Town.” The same is true almost 50 years later, as the U.S. Food and Drug Administration has announced its plan to phase out its general enforcement...more

Wilson Sonsini Goodrich & Rosati

FDA Signals to Industry to Prepare for Compliance with the LDT Final Rule Despite Looming Legal Challenge

The U.S. Food and Drug Administration (FDA) is reaffirming its plans to actively regulate certain laboratory developed tests (LDTs) that the FDA has historically treated with enforcement discretion. On June 25, 2024, the FDA...more

American Conference Institute (ACI)

U.S. Implications of the EU AI Act

The European Union (EU) is leading the global charge with AI regulations. U.S. companies are not beyond their regulatory reach, however, and should be preparing their AI risk mitigation efforts accordingly....more

Thomas Fox - Compliance Evangelist

How Transparency Reporting is Transforming Life Sciences

What is transparency reporting in life sciences? How does it impact your compliance program? I recently had the opportunity to visit with Lucas Croteau, an innovator in the life sciences compliance sector, to explore these...more

Smart & Biggar

CDA–AMC (formerly CADTH) announces several pilot projects, including Target Zero initiative

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CADTH is now known as Canada’s Drug Agency (CDA-AMC or CDA). Its mandate extends beyond CADTH’s mandate to include: improving the appropriate prescribing and use of medications; increasing pan-Canadian data collection and...more

Goodwin

FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests

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On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) published its...more

Arnall Golden Gregory LLP

Open Up Your Eyes: FDA Expects Real Transparency in ClinicalTrials.gov Disclosures

Based on client inquiries and FDA actions, the Food and Drug Administration is focusing more on companies not submitting data to www.ClinicalTrials.gov. It is taking stronger action against those companies it believes are...more

BakerHostetler

FDA Issues Much-Anticipated Final Rule on Laboratory Developed Tests

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The U.S. Food and Drug Administration (FDA) issued a final rule on April 29, 2024, that significantly changes the regulatory framework for laboratory developed tests (LDTs). LDTs are in vitro diagnostic products (IVDs) that...more

Holland & Knight LLP

FDA Announces Final Regulation Governing Laboratory Developed Tests

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The U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule that laboratory developed tests (LDTs) will be regulated as medical devices....more

Arnall Golden Gregory LLP

Welcome to the Machine: FDA Issues White Paper on AI and Medical Products

For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more

Smart & Biggar

Generic Submissions Under Review List Will Identify Generic Filers

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On February 23, 2024, Health Canada announced that it will expand the information available on the Generic Submissions Under Review (GSUR) list to include the following...more

Smart & Biggar

Update on biosimilars in Canada – March 2024

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In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update....more

Smart & Biggar

Minister of Health proposes legislation for first phase of national universal pharmacare

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On February 29, 2024, the Minister of Health announced the introduction of Bill C-64, An Act respecting pharmacare (Pharmacare Act), which “proposes the foundational principles for first phase of national universal pharmacare...more

Smart & Biggar

PMPRB releases 2022 Annual Report and March 2024 NEWSletter

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On February 16, 2024, the Minister of Health tabled the 2022 Annual Report of the Patented Medicine Prices Review Board (PMPRB). The 2022 Annual Report provides an overview of the PMPRB’s mandate, structure and price review...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: April 2024

Arguing that the National Science Foundation (NSF) was “intricately involved” when it made a $1.125 million fixed amount subaward, Oklahoma University (OU) objected to a recent finding by auditors for the NSF Office of...more

Mayer Brown

Brasília em Pauta – Edição Nº 148

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Anticorrupção e Compliance - TC 012.197/2019-0 e TC 012.198/2019-6 (TCU): embargos de declaração em face de acórdãos que negaram provimento aos recursos de reconsideração interpostos contra acórdãos que julgaram...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

Health Care Compliance Association (HCCA)

HHS OIG General Compliance Program Guidance: An empowered and independent compliance function

Corporate Compliance & Ethics Week 2023 kicked off with a gift for healthcare and life sciences compliance practitioners by way of the U.S. Department of Health and Human Services (HHS) Office of Inspector General’s (OIG)...more

Smart & Biggar

Dexlansoprazole formulation patent invalid and not infringed by Apotex

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On February 7, 2024, the Federal Court dismissed Takeda’s action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to dexlansoprazole (Takeda’s DEXILANT). Justice Furlanetto...more

Goodwin

Healthcare Experts See Promising Signs of Rebound in M&A and IPO Activity

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In the second week of January, Goodwin and KPMG convened innovators, practitioners, regulators, and others for our annual symposium on the future of life sciences and healthcare. This marked the fifth year that Goodwin...more

Health Care Compliance Association (HCCA)

Penn Calls for Withdrawal of ORI’s Misconduct Proposed Reg; Many Commenters Also Critical

The HHS Office of Research Integrity (ORI) gets an “A” for effort on its new proposed regulation revising research misconduct rules, but maybe a “D” overall. Most of the nearly 200 comments on the proposed rule posted online...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

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